Acellular Dermal Matrix vs Autologous Tarsus for Correction of Lower Eyelid Retraction

Prospective Comparison of Acellular Dermal Matrix and Autologous Tarsus for Correction of Lower Eyelid Retraction

The goal of this clinical trial is to compare the effectiveness of two promising implants in treatment of lower eyelid retraction in 40 patients. This condition often resulting from injury, surgical complications, or thyroid eye disease. The main questions it aims to answer are:

Which implant provides better long-term stability of the eyelid malposition?

Does one implant minimize complications and improve patient outcomes more effectively than the other?

This study will compare the use of donor sclera implants to a cellular dermal matrix to see if either offers superior results in terms of reducing graft shrinkage and improving eyelid positioning.

Participants will:

Undergo lower eyelid reconstruction surgery with one of the two implants.

Be monitored for postoperative outcomes, including eyelid position, recurrence rates, and complications over a follow-up period 6 months.

Study Overview

• Status: Recruiting
• Conditions: Lower Eyelid Retraction
• Intervention / Treatment: Procedure: Autologous tarsus; Procedure: Acellular dermal matrix

Detailed Description

The study aims to find the best way to surgically correct lower eyelid retraction, a condition where the lower eyelid droops, leading to eye dryness, irritation, and potential vision problems. This condition can arise from various causes like thyroid eye disease, complications from eyelid or eye socket surgeries, burns, or injuries. The goal of the study is to determine which "spacer" graft works best to lift the eyelid back into its correct position and provide long-lasting results.

Currently, there's no universally agreed-upon optimal spacer-graft for this condition. Surgeons at the department of Ophthalmology at Haukeland University Hospital are conducting a study to compare two promising spacer graft materials: acellular dermal matrix (Permacol), a processed tissue that encourages tissue regeneration, and autologous tarsus, tissue taken from the patient's own upper eyelid.

Forty patients needing surgery for lower eyelid retraction will be inculded in this study. They will be randomly assigned to receive either the Permacol graft or the autologous tarsus graft. The surgical procedure involves making an incision inside the lower eyelid, separating the retractors (muscles that pull the eyelid down), and inserting the chosen spacer graft between the tarsus (the eyelid's supporting structure) and the retractors. This lifts the eyelid to the correct position.

Patients will be followed up for six months after surgery. Doctors will measure the position of the eyelid, how well the eye closes, and signs of dryness or damage to the eye surface. Patients will also be asked about pain/discomfort, and satisfaction with the cosmetic outcome. The study will track any complications, such as infection or recurrence of the eyelid retraction.

The study will compare the two groups to see which graft provides better eyelid positioning, reduces symptoms, and has fewer complications. Statistical analysis will be used to determine if there are significant differences between the two treatment groups.

The results of this study will provide valuable information for surgeons treating lower eyelid retraction, helping them choose the most effective and safe graft material for their patients. The procedures will be performed by experienced surgeons at Haukeland University Hospital, ensuring patient safety. The study adheres to ethical guidelines, and patients will provide informed consent before participating.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hans Olav Ueland, MD, PhD; Phone Number: +4755975719; Email: uela@helse-bergen.no
• Study Contact Backup: Name: Annette Morwena Hope, MD; Phone Number: +47 41164804; Email: annette.morwena.hope@helse-bergen.no

Study Locations

• Norway
  • Vetslandet
    • Bergen, Vetslandet, Norway, 5021
      • Recruiting
      • Haukeland University Hospital
      • Contact: Annette Morwena Hope, MD; Phone Number: +4741164804; Email: annette.morwena.hope@helse-bergen.no
      • Contact: Kathrine Halsøy, MD; Phone Number: +4791788483; Email: kathrine.halsoy@helse-bergen.no
      • Principal Investigator: Hans Olav Ueland, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients aged 18-75 years.
• Grade 2 or higher lower eyelid retraction (according to the retraction grading scale).
• Candidate for surgical correction due to functional or cosmetic reasons.
• Willingness to participate and provide informed consent.

Exclusion Criteria:

• Active ocular or eyelid infection.
• History of severe scarring or keloid formation.
• Concurrent orbital or eyelid malignancies. Pregnancy or lactation. Uncontrolled systemic diseases (e.g., diabetes, immune disorders). Previous eyelid surgery on the affected eye.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Autologous tarsus; Surgical implantation to elongate the lower eyelid	Procedure: Autologous tarsus; Surgical implantation of autologous tarsus to the lower eyelid
Active Comparator: A cellular dermal matrix (Permacol); Surgical implantation to elongate the lower eyelid	Procedure: Acellular dermal matrix; Surgical implantation of acellular dermal matrix to the lower eyelid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medial reflex distance 2	Number of patients with ≥ 1 mm reduction in medial reflex distance 2	From baseline to 6 months follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vertical eyelid aperture	Number of patients with ≥ 1 mm reduction in vertical eyelid aperture	From baseline to 6 months follow-up.
Scleral show	Number of patients with ≥ 1 mm reduction in scleral show .	From baseline to 6 months follow-up.
Lagophthalmos	Number of patients with ≥ 1 mm reduction in lagophthalmos .	From baseline to 6 months follow-up.
Oxford staining scale	Number of patients with ≥ 1 reduction in Oxford staining scale (objective assessment of keratopathy). Oxford staining scale range from 0-4, and a higher score mean a worse outcome. .	From baseline to 6 months follow-up.

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Investigators: Principal Investigator: Hans Olav Ueland, MD, PhD, Haukeland University Hospital

Publications and helpful links

General Publications

• Ferri M, Oestreicher JH. Treatment of post-blepharoplasty lower lid retraction by free tarsoconjunctival grafting. Orbit. 2002 Dec;21(4):281-8. doi: 10.1076/orbi.21.4.281.8555.
• Tao JP, Aakalu VK, Wladis EJ, Sobel RK, Freitag SK, Foster JA, Yen MT. Bioengineered Acellular Dermal Matrix Spacer Grafts for Lower Eyelid Retraction Repair: A Report by the American Academy of Ophthalmology. Ophthalmology. 2020 May;127(5):689-695. doi: 10.1016/j.ophtha.2019.11.011. Epub 2019 Dec 30.
• Park E, Lewis K, Alghoul MS. Comparison of Efficacy and Complications Among Various Spacer Grafts in the Treatment of Lower Eyelid Retraction: A Systematic Review. Aesthet Surg J. 2017 Jul 1;37(7):743-754. doi: 10.1093/asj/sjx003.
• Zucal I, Waldner M, Shojaati G, Schweizer R, Klein HJ, Giovanoli P, Plock JA. Burn Scar Ectropion Correction: Surgical Technique for Functional Outcomes. Ann Plast Surg. 2022 Mar 1;88(3):271-276. doi: 10.1097/SAP.0000000000003047.
• Osaki TH, Monteiro LG, Osaki MH. Management of eyelid retraction related to thyroid eye disease. Taiwan J Ophthalmol. 2022 Feb 14;12(1):12-21. doi: 10.4103/tjo.tjo_57_21. eCollection 2022 Jan-Mar.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2032

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 14, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: eyelid malposition
• Other Study ID Numbers: 863946

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared outside the study group because concent is not obtained to share personal data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No